21 C.F.R. § 558.198 Diclazuril.
Title 21 - Food and Drugs
(a) Specifications. Type A medicated article containing 0.2 percent diclazuril. (b) Approvals. See No. 000061 in §510.600(c) of this chapter. (c) Related tolerances. See §556.185 of this chapter. (d) Conditions of use. (1) Chickens. For chickens it is used as follows: (2) Turkeys. For turkeys it is used as follows: [64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR 34830, May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, 2004]
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.198 Diclazuril.
---------------------------------------------------------------------------------------------------------------- Combination grams/ Diclazuril grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 0.91 (1 part per million .................... Broiler chickens: For Feed continuously. 000061 (ppm)). the prevention of Not for use in coccidiosis caused by hens producing Eimeria tenella, E. eggs for human necatrix, E. food.. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima..(ii) 0.91 (1 ppm)................ Bacitracin methylene Broiler chickens: As in As in item (i) of 000061 disalicylate 4 to item (i) of this this table. 50. table; for increased Bacitracin rate of weight gain methylene and improved feed disalicylate efficiency.. provided by 046573..(iii) 0.91 (1 ppm)............... Bacitracin methylene Broiler chickens: As in Feed continuously 000061 disalicylate 50 item (i) of this as the sole ration plus roxarsone 22.7 table; as an aid in throughout growing to 45.4. the prevention of period. Use as necrotic enteritis sole source of caused or complicated organic arsenic; by Clostridium spp. or drug overdose or other organisms lack of water may susceptible to result in leg bacitracin; for weakness. Not for increased rate of use in hens weight gain, improved producing eggs for feed efficiency, and human consumption. improved pigmentation.. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone provided by No. 046573 in § 510.600(c) of this chapter..(iv) 0.91 (1 ppm)................ Bacitracin methylene Broiler chickens: As in Feed continuously 000061 disalicylate 100 to item (i) of this as the sole ration 200 plus roxarsone table; as an aid in throughout growing 22.7 to 45.4. the control of period. Start at necrotic enteritis first clinical caused or complicated signs of disease; by Clostridium spp. or vary dosage of other organisms bacitracin based susceptible to on severity of bacitracin; for infection; increased rate of administer weight gain, improved continuously for 5 feed efficiency, and to 7 days or as improved pigmentation.. long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton (g/ton). Use as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone provided by No. 046573 in § 510.600(c) of this chapter..(v) 0.91 (1 ppm)................. Bambermycins 1 to 2. Broiler chickens: As in As in item (i) of 000061 item (i) of this this table. table); for increased Bambermycins rate of weight gain provided by and improved feed 057926.. efficiency..(vi) 0.91(1 ppm)................. Roxarsone 22.7 to Broiler chickens: As in Feed continuously 046573 45.4. item (i) of this as the sole ration table; for increased throughout growing rate of weight gain, period. Use as improved feed sole source of efficiency, and organic arsenic; improved pigmentation.. drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdraw 5 days before slaughter.. Roxarsone provided by No. 046573 in § 510.600(c) of this chapter..(vii) 0.91 (1 ppm)............... Virginiamycin 5..... Broiler chickens: As in As in item (i) of 000061 item (i) of this this table; table; for increased Virginiamycin rate of weight gain provided by and improved feed 066104.. efficiency..(viii) 0.91 (1 ppm).............. Virginiamycin 5 to Broiler chickens: As in As in item (i) of 000061 15. item (i) of this this table. table; for increased Virginiamycin rate of weight gain.. provided by 066104..----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination grams/ Diclazuril grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 0.91 (1 ppm)................. .................... Growing turkeys: For Feed continuously 000061 the prevention of as the sole coccidiosis caused by ration. Do not E. adenoeides, E. feed to breeding gallopavonis and E. turkeys. Not for meleagrimitis.. use in hens producing eggs for human consumption..(ii) 0.91 (1 ppm)................ Bacitracin methylene Growing turkeys: As in As in paragraph 000061 disalicylate 4 to paragraph (d)(2)(i) of (d)(2)(i) of this 50.. this section; for section. increased rate of Bacitracin weight gain and methylene improved feed disalicylate efficiency.. provided by No. 046573 in § 510.600(c) of this chapter..(iii) 0.91 (1 ppm)............... Bambermycins 1 to 2. Growing turkeys: As in As in paragraph 000061 paragraph (d)(2)(i) of (d)(2)(i) of this this section; for section. improved feed Bambermycins efficiency.. provided by No. 057926 in § 510.600(c) of this chapter..(iv) 0.91 (1 ppm)................ Bambermycins 2...... Growing turkeys: As in As in paragraph 000061 paragraph (d)(2)(i) of (d)(2)(i) of this this section; for section. increased rate of Bambermycins weight gain and provided by No. improved feed 057926 in § efficiency.. 510.600(c) of this chapter..----------------------------------------------------------------------------------------------------------------
